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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5

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BECTON DICKINSON DE MEXICO BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5 Back to Search Results
Catalog Number 308618
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Injury (2348)
Event Date 11/29/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that the bd¿ syringe 5ml ll 22ga 1-1/4in ptk 5 has been found containing foreign matter before use.The following has been provided by the initial reporter: basically i observe that in the ¿union¿ of the needle and the plastic it has a kind of ¿white silicone¿ that stands out and hurts the patient.The defect was noticed during, before and after the use.The customer relate a injury due to the puncture.There was no need for medical or surgical intervention.
 
Manufacturer Narrative
H.6 investigation summary: samples and photos received for investigation.18 with opened package, 1 without package, and 1 piece belonging to savings pharmacies are received by the client, additionally 15 pieces of needle without syringe are received, which were sent to the quality control laboratory for visual evaluation.Samples were evaluated for epoxy stains, and surface of the cannula for any notches, burrs, fractures, scratches, or corrosion presence.During the tests performed, there are no characteristics similar to those reported by the client detected.During the documentary review, no attributable problem was found for the defect reported, in addition, the samples provided by the client presented compliant results in the tests performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.
 
Event Description
It has been reported that the bd¿ syringe 5ml ll 22ga 1-1/4in ptk 5 has been found containing foreign matter before use.The following has been provided by the initial reporter: basically i observe that in the ¿union¿ of the needle and the plastic it has a kind of ¿white silicone¿ that stands out and hurts the patient.The defect was noticed during, before and after the use.The customer relate a injury due to the puncture.There was no need for medical or surgical intervention.
 
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Brand Name
BD SYRINGE 5ML LL 22GA 1-1/4IN PTK 5
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key9474978
MDR Text Key198363255
Report Number9614033-2019-00290
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2024
Device Catalogue Number308618
Device Lot Number9015861
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2019
Initial Date FDA Received12/16/2019
Supplement Dates Manufacturer Received11/29/2019
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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